Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties. Quantity: 1 box of 10 each (2 per pouch), sterilized by ETO, Federal law restricts this device to sale by or on the order of a physician. Manufactured by Sterion Incorporated, Ham Lake, MN for Argon Medical Devices, Athens, Texas.
FDA Recall Z-1044-04 · Posted 2004-07-20
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Recalling FirmArgon Medical Devices, Inc
Recall StatusTerminated
Product CodeKDC
Date Initiated2004-06-22
Date Terminated2005-11-03
Product Quantity5604 units
Reason for Recall
Inadequate closure compromising sterility.
Firm Action
The recall was initiated by certified letter on 06/22/2004.
Root Cause
Other
Distribution Pattern
Distribution ocurred in the following states PA, MO, NJ, OH, CA, VA, NM, TX, NE, and to Tokyo, Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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